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Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

NCT01543087 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 698

Last updated 2020-03-27

Study results available
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Summary

This study is to assess the longevity of immune response in adolescents for approximately 48 months after receipt of a primary series of bivalent rLP2086 vaccination, which is then followed by a booster dose and an assessment of immune response for 12 or 26 months post booster vaccination.

Conditions

  • Meningococcal Infection

Interventions

PROCEDURE

blood sampling

Blood sample collection at different time points

DRUG

bivalent rLP2086

A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Purpose
OTHER
Masking
NONE

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-07
Primary Completion
2018-01-05
Completion
2018-01-05
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543087 on ClinicalTrials.gov